March 31, 2008 

 

The Honorable Stephen Johnson 

Administrator 

U.S. Environmental Protection Agency 

Ariel Rios Building 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20460 

 

 

Dear Administrator Johnson: 

 

Enclosed for your consideration is the Report of the Small Business Advocacy Review 

Panel (SBAR Panel or Panel) convened for EPA’s planned proposed rulemaking entitled 
“Revisions to the Total Coliform Monitoring and Analytical Requirements and 
Consideration of Distribution System Issues.” Possible revisions to the Total Coliform 
Rule (TCR) are being developed by the U.S. Environmental Protection Agency (EPA) 
under the Safe Drinking Water Act (SDWA). 

 

The TCR was promulgated on June 29, 1989 and became effective on December 31, 
1990. The TCR requires all Public Water Systems (PWSs) to monitor for the presence of 
total coliforms in the drinking water distribution system. Total coliforms are a group of 
closely related bacteria that are (with few exceptions) not harmful to humans. Because 
total coliforms are common inhabitants of ambient water, and because they may be 
injured by environmental stresses and water treatment in a manner similar to most 
bacterial pathogens and many viral enteric pathogens, EPA has considered them a useful 
indicator of these pathogens. The TCR includes maximum contaminant levels (MCLs) 
for total coliforms (TC) and fecal coliforms (FC), and has requirements for public 
notification (PN) when MCL violations occur. The TCR also includes requirements for 
reporting and recordkeeping and periodic sanitary survey inspections of the water system. 

 

The SDWA requires EPA to review existing national primary drinking water regulations 
every six years. In 2003, EPA completed its Six-Year Review of the TCR and provided 
public notice of its intent to revise the Total Coliform Rule. As part of the planned TCR 
revisions, EPA intends to assess the effectiveness of the current TCR and determine 
whether technically supportable alternative/additional monitoring strategies are available 
that would decrease economic burden while maintaining or improving public health 
protection. The SDWA requires that public health protection be maintained or improved 
any time EPA revises a drinking water regulation. 

 

In conjunction with its consideration of TCR revisions, EPA is also considering if and 
how risks associated with drinking water distribution systems should be addressed. This 
evaluation is being conducted to address the recommendations of the Stage 2 Microbial/ 


Disinfection Byproducts Federal Advisory Committee (M/DBP FAC) “Agreement in 
Principle” that was completed in 2000. That Advisory Committee was formed to make 
recommendations concerning two other drinking water rules, the Long-Term 2 Enhanced 
Surface Water Treatment Rule and the Stage 2 Disinfection Byproducts Rule. In its 
Agreement in Principle, the M/DBP FAC recommended that EPA review and evaluate 
available data and research on those aspects of distribution systems that may create or 
pose risks to public health. The M/DBP FAC also concluded that EPA should initiate a 
process with stakeholder participation for addressing requirements for cross-connection 
control and backflow prevention, and other distribution systems issues related to 
significant health risks. EPA is conducting the distribution system data and research 
review and the stakeholder participation process in conjunction with the consideration of 
the TCR revisions. 

 

In July 2007, EPA convened a Total Coliform Rule/Distribution System Federal 
Advisory Committee (TCRDSAC) charged with evaluating how well the objectives of 
the TCR are met and possible revisions to the rule. The TCRDSAC is scheduled to 
complete its analysis and recommendations by the summer of 2008. The SBAR Panel 
will inform the TCRDSAC of the findings in this report before the TCRDSAC completes 
its final analysis and recommendations. 

 

On January 31, 2008, EPA’s Small Business Advocacy Chairperson convened this Panel 
under section 609(b) of the Regulatory Flexibility Act (RFA), as amended by the Small 

Business Regulatory Enforcement Fairness Act (SBREFA). In addition to its chairperson, 
the Panel consists of the Director of the Standards and Risk Management Division within 
EPA’s Office of Ground Water and Drinking Water, the Administrator of the Office of 
Information and Regulatory Affairs within the Office of Management and Budget 
(OMB), and the Chief Counsel for Advocacy of the Small Business Administration 
(SBA). It is important to note that the Panel’s findings and discussion are based on the 
information available at the time this report was drafted. EPA is continuing to conduct 
analyses relevant to the proposed rule, and additional information may be developed or 
obtained during this process as well as from public comment on the proposed rule. The 
options the Panel identified for reducing the rule’s economic impact on small entities will 
require further analysis and/or data collection to ensure that the options are practicable, 
enforceable, protective of public health, environmentally sound and consistent with the 
SDWA. 

 

 

SUMMARY OF SMALL ENTITY OUTREACH 

 

EPA is involving stakeholders very early in the rule revision process to ensure the quality 
of information on affected entities, identify and understand potential implementation and 
compliance issues, and explore regulatory alternatives. In the process, EPA received 
direct input from small PWSs (those that serve less than 10,000 persons per day) and 
their industry representatives about the possible impacts of the planned proposed rule 
revisions. 


 

Prior to convening the Panel, EPA conducted outreach with small entities that will 
potentially be affected by these regulations. In November 2007, EPA invited SBA, 
OMB, and 23 potentially affected small PWSs and industry representatives to a 
conference call and solicited comments from them on preliminary information sent to 
them. EPA shared the small entities’ written comments with the Panel as part of the Panel 
convening document. 

 

After the SBAR Panel was convened, the Panel distributed additional information to the 
small entity representatives (SERs) on January 31, 2008, for their review and comment 
and in preparation for another outreach meeting. On February 25, 2008, the Panel met 
with the SERs to hear their comments on the information distributed in these mailings. 
The SERs were asked to provide written feedback on ideas under consideration for the 
proposed rulemaking and responses to questions regarding their experience with the 
existing TCR requirements. The Panel received written comments from the SERs in 
response to the discussions at this meeting and the outreach materials. See Section 8 of 
the Panel Report for a complete discussion of SER comments. Their full written 
comments are also attached. In light of these comments, the Panel considered the 
regulatory flexibility issues specified by RFA/SBREFA and developed the findings and 
discussion summarized below. 

 

 

PANEL FINDINGS AND DISCUSSION 

 

Under section 609(b) of the RFA, the Panel is to report its findings related to these four 
items: 

 

1) A description of and, where feasible, an estimate of the number of small 
entities to which the proposed rule will apply. 




 

2) A description of the projected reporting, recordkeeping and other compliance 
requirements of the proposed rule, including an estimate of the classes of 
small entities which will be subject to the requirement and the type of 
professional skills necessary for preparation of the report or record. 




 

3) Identification, to the extent practicable, of all relevant federal rules which may 
duplicate, overlap or conflict with the proposed rule. 




 

4) A description of any significant alternatives to the planned proposed rule 
which would minimize any significant economic impact of the proposed rule 
on small entities consistent with the stated objectives of the authorizing 
statute. 




 


The Panel’s most significant findings and discussion with respect to each of these items 
are summarized below. To read the full discussion of the Panel findings and 
recommendations, see Section 9 of the Panel Report. 

 

 A. Number and Types of Entities Affected 

 

For a complete description and estimate of the small water systems to which the proposed 
revised rule will apply, see Section 5 of the Report. The total number of small systems 
possibly affected by the rule revisions is estimated at 153,868. The types of small 
systems affected could be Community Water Systems (public water systems which serve 
at least 15 service connections used by year-round residents or regularly serves at least 25 
year-round residents) or Non-Community Water Systems, such as restaurants, parks, 
schools or factories with their own water system. Small Entity Representatives (SERs) 
noted the large number of small systems possibly impacted and suggested that different 
requirements might be advisable for different classes of systems based on system type, 
size, and configuration. The Panel notes that the current TCR already establishes 
different requirements based on system size and type, but recommends that EPA continue 
to evaluate whether it is appropriate to further differentiate TCR requirements based on 
the differences in water systems. Additional recommendations regarding how 
requirements can be tailored to different system types and sizes are indicated in the 
following sections. 

 

 B. Recordkeeping, Reporting, and Other Compliance Requirements 

 

For any drinking water program, EPA must have assurances that the drinking water 
provided to the public will meet the health-based drinking water MCLs and treatment 
requirements. Historically, EPA drinking water requirements, including the current TCR, 
have included requirements for public water system recordkeeping and reporting. The 
current TCR includes reporting and recordkeeping requirements for monitoring results, 
PN, and sanitary surveys. At the same time, the Paperwork Reduction Act (PRA) 
requires that all reporting and recordkeeping requirements have practical utility and 
appropriately balance the needs of government with the burden on the public. As EPA 
proceeds with any revisions to the requirements of the current TCR, EPA will also assess 
the need for revisions to reporting and recordkeeping requirements and will consider 
them in any estimation of the burden and benefits of the rule changes. EPA is committed 
to keeping paperwork requirements to the minimum necessary to fulfill its statutory 
obligations, as required by the PRA. 

 

C. Related Federal Rules 

 

The Panel is aware that numerous drinking water regulations are related to the TCR, 
including the Surface Water Treatment Rule, three enhanced surface water treatment 
rules (Interim, Long Term 1 and Long Term 2 Enhanced Surface Water Treatment), the 
Total Trihalomethanes, Stage 1 and Stage 2 Disinfectants and Disinfection Byproducts 
Rules, and the Ground Water Rule. The Panel is aware of how the requirements of these 


rules might relate to possible revised TCR requirements, and the relationships were 
discussed with the SERs at the outreach meetings. For a detailed description of these 
related rules, see section 2.3 of the Report. The Panel notes that these rules have all been 
developed with careful attention to the interaction between each new rule addressing 
microbial and disinfection issues and the earlier rules addressing these issues. The Panel 
recommends that EPA continue to ensure that any revisions to the TCR be coordinated 
with, and do not either duplicate or conflict with, the requirements of these other rules. 
Specifically, the Panel recommends that EPA consider how best to conform the sanitary 
survey requirements that appear in the different rules. 

 

 D. Regulatory Flexibility Alternatives 

 

 1. MCLs, Corrective Action and Public Notification 

 

As described in Section 2.2 of the report, under the current TCR, a monthly (non-acute) 
MCL violation has occurred if more than 5.0 percent of distribution system samples 
collected in any month are total coliform positive (TC (+)). For PWSs serving 33,000 or 
fewer people, this means that no more than 1 sample per month may be TC (+), because 
these PWSs collect fewer than 40 samples per month. When the number of TC (+) 
samples exceeds these limits a monthly MCL violation has occurred, and the PWS must 
notify the State by the end of the next business day after the PWS learns of the violation, 
and must notify the public within 30 days. The SERs commented that this requirement is 
ineffective, confusing, and leads to unnecessary public distrust of the water system, 
because total coliforms do not themselves represent a health risk and the notification 
usually comes well after the incident occurred and water quality has returned to normal. 

 

SERs also suggested that TC (+) samples could serve a better purpose by triggering 
assessment or corrective action requirements appropriate to the water system type and 
complexity. SERs also emphasized the wide variability in system sources, 
configurations, and issues and indicated that any corrective action requirements should 
leave flexibility to the operator to respond to the detection in an appropriate manner, 
which might range from merely confirming that a TC (+) result was an isolated incident 
of short duration, to major rehabilitation of the system in cases where the detection turned 
out to be indicative of significant structural problems. 

 

The Panel believes that the TCR as revised should continue to meet the three objectives 
of the 1989 rulemaking: to ensure integrity of the distribution system, indicate 
effectiveness of treatment, and indicate possible fecal contamination. The Panel 
supports an approach which uses TC as a trigger for investigation and/or corrective action 
rather than as the basis for an MCL violation and notification to the public. With the 
appropriate monitoring, investigation, and corrective action elements, the Panel believes 
that such an approach can be structured to satisfy the SDWA requirement that any revised 
regulation at least maintain the level of public health protection of existing regulations. 
Under such as approach, TC (+) results would still require immediately follow up or 
concurrent testing for E. coli, and E. coli positive results would serve as the basis for an 


acute MCL violation and as a trigger for immediate public notification. The Panel further 
recommends that EPA develop a toolbox of appropriate enforceable investigative and 
corrective action responses. The Panel recognizes that in many cases system operators 
and primacy state regulatory authorities have considerable expertise in system operations, 
and encourages EPA to develop an approach that includes flexibility to rely on this 
expertise where appropriate. 

 

 

 2. Monitoring 

 

The Panel notes that several SERs were concerned that the monitoring scheme in the 
current TCR allows States to reduce monitoring to quarterly or annually for some classes 
of systems (such as small non-community systems), and that such reduced monitoring 
schemes may not be sufficiently protective of public health. The Panel recommends that 
EPA develop options that would ensure that routine monitoring and any provisions for 
reduced monitoring appropriately balance risk and cost/burden and ensure protection of 
public health. This could include targeting more frequent monitoring for small 
community and/or non-community systems to high risk sites or systems. The Panel also 
recommends that, when considering criteria under which systems could reduce 
monitoring from the baseline, or would be required to increase monitoring back to the 
baseline after it has been reduced, EPA should consider public health protection and the 
resources required in tracking changes in monitoring frequency. Examples of criteria that 
may be appropriate for determining the frequency of monitoring include system size, 
sanitary survey results, compliance history, past monitoring results, system configuration 
(e.g. distribution system vs. no distribution system), source type, source water 
vulnerability, treatment in place (e.g. disinfection) and operator training. 

 

SERs also commented that requirements should be different for water systems without a 
distribution system, especially TNCWSs, because the system is much simpler and less 
vulnerable to sanitary breaches. More generally, most SERs expressed concern with the 
current repeat and next-month routine sampling requirements following a TC (+) result. 
For example, it may not make sense to require multiple repeat samples for a system 
without a distribution system that has only one tap. Therefore, the Panel recommends 
that EPA specifically tailor small system repeat monitoring requirements to the 
characteristics and situations of different system types, where practicable. One approach 
may be to allow greater flexibility in the number and location of repeat samples, with 
appropriate state oversight. 

 

The Panel also recommends that EPA continue to evaluate what parameters are most 
appropriate for routine monitoring and as potential triggers for investigative and 
corrective action. Specifically, EPA should assess the advantages and disadvantages of 
continuing to allow FC as an alternative indicator to E. coli and the appropriate role for 
monitoring disinfectant residual. The Panel also recommends that EPA continue to 
evaluate the possible use of methods that will provide a rapid result for both TC and E. 
coli, so that any additional monitoring, assessment, and corrective action can be